CN104940930A - Oral medicine emulsion for treating pediatric epilepsy, and preparation method thereof - Google Patents
Oral medicine emulsion for treating pediatric epilepsy, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an oral medicine emulsion for treating pediatric epilepsy. Each 100ml of the oral medicine emulsion for treating pediatric epilepsy contains 0.1-10g of an anti-epileptic medicine, 1-100g of medicinal oil, 0.1-50g of an emulsifier, 0-20g of an auxiliary emulsifier, 0-10g of an antioxidant, and the balance of purified water. The invention discloses a preparation method of the oral medicine emulsion for treating pediatric epilepsy. The above composition has a protruding synergistic treatment effect on the epileptic disease. The oral medicine emulsion combining the anti-epileptic medicine with the medicinal oil, the emulsifier, the auxiliary emulsifier and the antioxidant has an extraordinary clinic use effect.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to one and treat epilepsy in childhood drug oral Emulsion, the invention still further relates to a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion.
Background technology
The technical disadvantages that the epilepsy medication of different dosage form exists comprises: for injection, and children's has and kind fears sense, is difficult to consciously to use with doctor, parental cooperation on time; For capsule, when children's uses less than one, usually take the medicine in capsule to be poured out the method with mixing in water for oral taking; For tablet; when the not enough a slice of pediatric dose, artificially need split, cause divided dose inaccurate; some coated tablet, slow releasing tablet lose its specifically effect such as effect as protection, taste masking, controlled release, isolation after artificially splitting, not yet have the report of antiepileptic Orally taken emulsion at present.
Summary of the invention
The object of this invention is to provide one and treat epilepsy in childhood drug oral Emulsion, this oral latex emulsion facilitates single dose to take, effective reduction child takes medicine fear phenomenon, make it become to be easy to the drug form accepted, effectively hide the bad smell of medicine, the fruit taste that child likes can be modulated into, good mouthfeel, do not limit by environment and condition, do not need drinking-water, can directly take.
Another object of the present invention is to provide a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion.
First technical scheme of the present invention is, one treats epilepsy in childhood drug oral Emulsion, every 100ml treats in epilepsy in childhood drug oral Emulsion containing antiepileptic 0.1g ~ 10g, medicinal oil 1g ~ 100g, emulsifying agent 0.1g ~ 50g, coemulsifier 0g ~ 20g, antioxidant 0g ~ 10g, surplus is purified water.
Feature of the present invention is also,
Antiepileptic comprise in sodium valproate, magnesium valproate, carbamazepine, oxcarbazepine, lamotrigine, topiramate, gabapentin, non-ammonia ester, phenobarbital, primidone, levetiracetam, zonisamide, ilepcimide, vanillin or asarone one or several.
Medicinal oil is one or several in vegetable oil, animal oil, mineral oil or quintessence oil.
Vegetable oil be soybean oil, Oleum Ricini, Oleum Arachidis hypogaeae semen, Oleum sesami, Semen Maydis oil, Oleum Camelliae and artificial oil acetoacetic ester, butyl oleate one or several; Soybean oil be selected from long chain triglyceride, medium chain triglyceride, glycerin mono-fatty acid ester, glyceryl monolinoleate one or several.
Emulsifying agent is one or more in nonionic emulsifier, anionic emulsifier and naturally occurring emulsifying agent; Nonionic emulsifier is selected from that fatty acid Pyrusussuriensis is smooth, Polysorbate, polyoxyethylene fatty acid ester class, polyoxyethylene aliphatic alcohol ether class, Pluronic F68 class, polyox-yethylene-polyoxypropylene block copolymer class, fatty acid monoglyceride, triglycerin fatty acid ester, polyglyceryl fatty acid ester, sucrose fatty acid ester and glyceryl monostearate one or more; Anionic emulsifier is selected from one or more mixture of sodium stearate, potassium stearate, enuatrol, potassium oleate, calcium stearate, sodium lauryl sulphate, hexadecyl hydrosulfate Oleum Ricini; Naturally occurring emulsifying agent is selected from one or more in arabic gum, tragakanta, gelatin and phospholipid.
Coemulsifier be the coemulsifier that increases aqueous phase viscosity and increase in the coemulsifier of oil phase viscosity one or more, the coemulsifier increasing aqueous phase viscosity is selected from one or more in methylcellulose, sodium carboxymethyl cellulose, carboxy-propyl cellulose, sodium alginate, agar, tragakanta, arabic gum, xanthan gum, guar gum, pectin, Bentonite; The coemulsifier increasing oil phase viscosity is selected from one or more in spermol, Cera Flava, glyceryl monostearate, stearic acid, stearyl alcohol, glycerol, Polyethylene Glycol, polyglycerin ester, polyvidone.
Antioxidant be sodium sulfite, sodium sulfite, sodium thiosulfate, sodium pyrosulfite, ascorbic acid, propyl gallate, ascorbyl palmitate, butylated hydroxyarisol, ditertbutylparacresol, vitamin E one or more.
Second technical scheme of the present invention is, a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion is specifically implemented according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, 40 ~ 80 DEG C of lower magnetic forces stir 10 ~ 60min, and high-speed shearing machine shears 1 ~ 30min, and embedding, sterilizing, obtains product.
3rd technical scheme of the present invention is, a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion is specifically implemented according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, through ultrasonic emulsator dispersion, 100W ~ 1000W, 1 ~ 5min, in triplicate, embedding, sterilizing, obtains product.
4th technical scheme of the present invention is, a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion is specifically implemented according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, 40 ~ 80 DEG C of preheatings, obtained oil phase is for subsequent use;
Step 3, under slow stirring, by load weighted coemulsifier and purified water mixing, and 40 ~ 80 DEG C of preheatings, obtain co-emulsifier agent solution, in the mode of thin jet, co-emulsifier agent solution is joined in the oil phase of preheating, form stable O/W type Emulsion, embedding, sterilizing, obtains product.
The invention has the beneficial effects as follows: huge for current epileptic group, the antiepileptic market demand obviously increases, and the antiepileptic of safe, effective and applicable child is under-supply, dosage form lacks, there is the present situation of potential safety hazard in clinical practice, develop and be suitable for the antiepileptic Orally taken emulsion of children taking, under the prerequisite ensureing principal agent appropriate dosage, be conducive to the absorption of medicine, improve bioavailability, the accuracy of dosage and drug safety.Also provide more, renewal, better dosage form selection for clinical, the availability of treat Patients with Epilepsy in Childhood and compliance will have very big improvement simultaneously.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described in detail.
The invention provides one and treat epilepsy in childhood drug oral Emulsion, every 100ml treats in epilepsy in childhood drug oral Emulsion containing antiepileptic 0.1g ~ 10g, medicinal oil 1g ~ 100g, emulsifying agent 0.1g ~ 50g, coemulsifier 0g ~ 20g, antioxidant 0g ~ 10g, surplus is purified water.
Wherein, antiepileptic comprises one or several in sodium valproate, magnesium valproate, carbamazepine, oxcarbazepine, lamotrigine, topiramate, gabapentin, non-ammonia ester, phenobarbital, primidone, levetiracetam, zonisamide, ilepcimide, vanillin or asarone.
Medicinal oil is one or several in vegetable oil, animal oil, mineral oil or quintessence oil.
Vegetable oil be soybean oil, Oleum Ricini, Oleum Arachidis hypogaeae semen, Oleum sesami, Semen Maydis oil, Oleum Camelliae and artificial oil acetoacetic ester, butyl oleate one or several; Soybean oil be selected from long chain triglyceride, medium chain triglyceride, glycerin mono-fatty acid ester, glyceryl monolinoleate one or several.
Emulsifying agent is one or more in nonionic emulsifier, anionic emulsifier and naturally occurring emulsifying agent; Nonionic emulsifier is selected from that fatty acid Pyrusussuriensis is smooth, Polysorbate, polyoxyethylene fatty acid ester class, polyoxyethylene aliphatic alcohol ether class, Pluronic F68 class, polyox-yethylene-polyoxypropylene block copolymer class, fatty acid monoglyceride, triglycerin fatty acid ester, polyglyceryl fatty acid ester, sucrose fatty acid ester and glyceryl monostearate one or more; Anionic emulsifier is selected from one or more mixture of sodium stearate, potassium stearate, enuatrol, potassium oleate, calcium stearate, sodium lauryl sulphate, hexadecyl hydrosulfate Oleum Ricini; Naturally occurring emulsifying agent is selected from one or more in arabic gum, tragakanta, gelatin and phospholipid.
Coemulsifier be the coemulsifier that increases aqueous phase viscosity and increase in the coemulsifier of oil phase viscosity one or more, the coemulsifier increasing aqueous phase viscosity is selected from one or more in methylcellulose, Sodium Tvlose, carboxy-propyl cellulose, sodium alginate, agar, tragakanta, arabic gum, xanthan gum, guar gum, pectin, Bentonite; The coemulsifier increasing oil phase viscosity is selected from one or more in spermol, Cera Flava, glyceryl monostearate, stearic acid, stearyl alcohol, glycerol, Polyethylene Glycol, polyglycerin ester, polyvidone.
Antioxidant be sodium sulfite, sodium sulfite, sodium thiosulfate, sodium pyrosulfite, ascorbic acid, propyl gallate, ascorbyl palmitate, butylated hydroxyarisol, ditertbutylparacresol, vitamin E one or more.
For exploitation is suitable for the dosage form of children taking, the dosage form drafting this product is Orally taken emulsion; Foundation is chosen as with the existing preparation process of commercial oral Emulsion, quality standard and adjuvant, we screen the selection of different auxiliary material and consumption, with appearance character, mouthfeel, drug solubility, pH is leading indicator, determines the consumption of adjuvant, and through optimization, the stability test result of prescription, carry out the Formulation of epilepsy in childhood drug oral Emulsion; The span of each component is finally determined according to child's common dose.
Epilepsy in childhood drug oral Emulsion of the present invention, the disagreeable taste of carrying antiepileptic adopts coating taste masking technology or taste masking technology, cover the pungent bitterness of medicine, by medicine first being made coated micropill or adopting inclusion technique to prepare clathrate, then add in Emulsion.
Emulsification method of the present invention can select phase conversion emulsifying, PIT emulsion process, alternately liquid feeding emulsion process, ultrasonic emulsification, low-energy emulsification method, microfluidization etc.
Emulsifying device of the present invention can select constant temperature blender with magnetic force, colloid mill, high speed dispersor, ultrasonic emulsator, high speed agitator, high pressure homogenizer etc.
The present invention also provides a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion, specifically implements according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, 40 ~ 80 DEG C of lower magnetic forces stir 10 ~ 60min, and high-speed shearing machine shears 1 ~ 30min, and embedding, sterilizing, obtains product.
The present invention also provides a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion, specifically implements according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, through ultrasonic emulsator dispersion, 100W ~ 1000W, 1 ~ 5min, in triplicate, embedding, sterilizing, obtains product.
The present invention also provides a kind of preparation method for the treatment of epilepsy in childhood drug oral Emulsion, specifically implements according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, 40 ~ 80 DEG C of preheatings, obtained oil phase is for subsequent use;
Step 3, under slow stirring, by load weighted coemulsifier and purified water mixing, and 40 ~ 80 DEG C of preheatings, obtain co-emulsifier agent solution, in the mode of thin jet, co-emulsifier agent solution is joined in the oil phase of preheating, form stable O/W type Emulsion, embedding, sterilizing, obtains product.
Embodiment 1
The preparation method of the treatment epilepsy in childhood drug oral Emulsion of the present embodiment 1, specifically implements according to following steps: weigh following component: (phase conversion emulsifying)
Step 1, weighing, weigh following component: sad certain herbaceous plants with big flowers acid triglyceride 10g, sodium valproate 2g, phosphatidase 5 .4g, vitamin E 0.1g, PLURONICS F87 0.54g, glycerol 2.5g, and surplus is purified water, and above total amount is 100ml;
Step 2, prepare oil phase, by load weighted in step 1 sad certain herbaceous plants with big flowers acid triglyceride, sodium valproate, phospholipid, vitamin E oil soluble components mix homogeneously, obtained oil phase, 40 ~ 80 DEG C of insulations are for subsequent use; To join in oil phase after PLURONICS F87, glycerol and water mixed dissolution, 40 ~ 80 DEG C of lower magnetic forces stir 10 ~ 60min, and high-speed shearing machine shears 1 ~ 30min, and embedding, sterilizing, obtains product.
Embodiment 2
The preparation method of the treatment epilepsy in childhood drug oral Emulsion of the present embodiment 2, specifically implements according to following steps: weigh following component: ultrasonic emulsification
Step 1, weighing, weigh following component: magnesium valproate 10g, glycerin mono-fatty acid ester 1g, sodium stearate 30g, enuatrol 20g, glyceryl monostearate 20g, sodium pyrosulfite 0g; Surplus is purified water, and above total amount is 100ml;
Step 2, prepare oil phase, by magnesium valproate load weighted in step 1, glycerin mono-fatty acid ester, sodium stearate, enuatrol, sodium pyrosulfite oil-soluble ingredients mix homogeneously, obtained oil phase is for subsequent use; To join in oil phase after purified water and glyceryl monostearate mixed dissolution, through ultrasonic emulsator dispersion, 100W ~ 1000W, 1 ~ 5min, in triplicate, embedding, sterilizing, obtains product.
Embodiment 3
The preparation method (microfluidization) of the treatment epilepsy in childhood drug oral Emulsion of the present embodiment 3, specifically implement according to following steps:
Step 1, weighing, weigh following component: topiramate 0.1g, Oleum Ricini 50g, triglycerin fatty acid ester 0.05g, gelatin 0.05g, sodium carboxymethyl cellulose 0.1g, sodium alginate 0g, sodium sulfite 0g; Surplus is purified water, and above total amount is 100ml;
Step 2, prepare oil phase, by topiramate load weighted in step 1, Oleum Ricini, triglycerin fatty acid ester, gelatin, sodium sulfite oil-soluble ingredients mix homogeneously, 40 ~ 80 DEG C of preheatings, obtained oil phase is for subsequent use; Under slow stirring, join in the oil phase of preheating in the mode of thin jet by the purified water including sodium carboxymethyl cellulose and sodium alginate of 40 ~ 80 DEG C of preheatings, form stable O/W type Emulsion, embedding, sterilizing, obtains product.
Embodiment 4
The preparation method (microfluidization) of the treatment epilepsy in childhood drug oral Emulsion of the present embodiment 4, specifically implement according to following steps:
Step 1, weighing, weigh following component: topiramate 0.1g, Oleum Ricini 50g, triglycerin fatty acid ester 0.05g, gelatin 0.05g, surplus is purified water, and above total amount is 100ml;
Step 2, prepare oil phase, by topiramate load weighted in step 1, Oleum Ricini, triglycerin fatty acid ester, gelatin oil-soluble ingredients mix homogeneously, 40 ~ 80 DEG C of preheatings, obtained oil phase is for subsequent use; Under slow stirring, join in the oil phase of preheating in the mode of thin jet by the purified water of 40 ~ 80 DEG C of preheatings, form stable O/W type Emulsion, embedding, sterilizing, obtains product.
Test example 1 antiepileptic Orally taken emulsion is to the prevention and treatment of mice epilepsy
1 data and method:
1.1 laboratory animals: SD rat, about body weight 300g, male and female half and half.Purchased from Heilongjiang Prov. Tumour Hospital's Experimental Animal Center, by penicillin injection, make epilepsy model.
1.2 medicines:
Self-control sodium valproate Emulsion, specification: 0.2g.
Commercially available sodium valproate sheet, specification: 0.2g, by Brassica rapa L, flat pharmaceutcal corporation, Ltd produces, lot number: 140804.
2. experimental technique:
Get SD rat, be divided into 3 groups at random, often organize 10, be respectively blank group, marketed drugs group, Orally taken emulsion group.Each group of rat is with ether light anesthesia, and lumbar injection penicillin 6,000,000 U/kg, inject and start gastric infusion in first 1 day, dosage is 3.5 × 10
-3g/kg (by sodium valproate), one day twice, for three days on end.Observe its behavior expression.
As shown in table 1, experimental result shows, Orally taken emulsion group, street drug group compare with blank group, relatively its convulsions induction period, convulsions rate, there is pole significant difference (P<0.01), and Orally taken emulsion group compares P>0.05 with street drug group, show Orally taken emulsion group and street drug group there was no significant difference.
Table 1 antiepileptic Orally taken emulsion is to the prevention and treatment of mice epilepsy
| Embodiment | Number of animals | Convulsions induction period | Convulsions rate (%) |
| Blank group | 10 | 1.5 | 100 |
| Street drug group | 10 | 3.5 | 75 |
| Orally taken emulsion group | 10 | 4 | 70 |
As can be seen from Table 1, mice convulsion rate can significantly be reduced after result antiepileptic Orally taken emulsion gastric infusion; Can obviously extend mice convulsion induction period.Conclusion shows that antiepileptic Orally taken emulsion has obvious anticonvulsant action.Confirm that antiepileptic Orally taken emulsion all has obvious preventive and therapeutic effect to the large and small outbreak of epilepsy.Prove that antiepileptic is made Orally taken emulsion and played ideal effect equally with other antiepileptic dosage forms, therefore show that the antiepileptic of antiepileptic Orally taken emulsion and other dosage forms has bioequivalence.
Clinical efficacy of the present invention:
Orally taken emulsion of the present invention effectively can treat epilepsy.Clinical experiment for many years by carrying out countless patient, its result all achieves significant curative effect.Now with the situation of 50 routine patient's pertinent clinical treatments, details are as follows.
Clinical data: collect the typical patient of 50 routine symptom suffering from epilepsy, carry out the clinical experiment of preparation of the present invention.These 50 patient male 28 examples, women 22 example, oldest 16 years old, minimum 3 years old, 7 years old mean age, is divided into test group 25 example, matched group 25 example at random.
Therapeutic Method: treat according to embodiment 1 gained preparation, therapeutic modality is oral, takes secondary on 1st, each 1 (10ml/ props up); Set up matched group, oral sodium valproate sheet (0.2g/ sheet), an a slice, a twice-daily simultaneously; And can according to patient's concrete state of an illness adjustment dosage.Clinical investigation is carried out after 3 months.
According to antiepileptic criterion of therapeutical effect in " drugs for nervous guideline of clinical investigations " that Ministry of Public Health is formulated: clinical efficacy is divided into show and carries out Clinical efficacy comparison into above (symptom improvement rate >=50%), progressive (symptom improvement rate >=25%) and invalid (symptom improvement rate < 25%) Three Estate.
Therapeutic outcome statistics is as table 1:
Table 1 clinical treatment outcome
| Standard | Treatment group (example) | Matched group (example) |
| Show into above | 42 | 38 |
| Progressive | 7 | 10 |
| Invalid | 1 | 2 |
Clinical effectiveness shows, the present composition has better effects to treatment epileptic condition, and the head of a family and infant generally react Orally taken emulsion taste well, and swallowing property is good, and drug compliance is good.Antiepileptic and medicinal oil are described, emulsifying agent, coemulsifier, the Clinical practice effect that the combination of antioxidant has same solid antiepileptic same, are even better than solid preparation, meet children demand simultaneously.
Claims (10)
1. treat an epilepsy in childhood drug oral Emulsion, it is characterized in that, every 100ml treats in epilepsy in childhood drug oral Emulsion containing antiepileptic 0.1g-10g, medicinal oil 1g ~ 100g, emulsifying agent 0.1g-50g, coemulsifier 0g ~ 20g, antioxidant 0g ~ 10g, surplus is purified water.
2. treatment epilepsy in childhood drug oral Emulsion according to claim 1, it is characterized in that, described antiepileptic comprise that antiepileptic comprises in sodium valproate, magnesium valproate, carbamazepine, oxcarbazepine, lamotrigine, topiramate, gabapentin, non-ammonia ester, phenobarbital, primidone, levetiracetam, zonisamide, ilepcimide, vanillin or asarone one or several.
3. treatment epilepsy in childhood drug oral Emulsion according to claim 1, is characterized in that, described medicinal oil is one or several in vegetable oil, animal oil, mineral oil or quintessence oil.
4. treatment epilepsy in childhood drug oral Emulsion according to claim 3, is characterized in that, described vegetable oil be soybean oil, Oleum Ricini, Oleum Arachidis hypogaeae semen, Oleum sesami, Semen Maydis oil, Oleum Camelliae and artificial oil acetoacetic ester, butyl oleate one or several; Soybean oil be selected from long chain triglyceride, medium chain triglyceride, glycerin mono-fatty acid ester, glyceryl monolinoleate one or several.
5. treatment epilepsy in childhood drug oral Emulsion according to claim 1, it is characterized in that, described emulsifying agent is one or more in nonionic emulsifier, anionic emulsifier and naturally occurring emulsifying agent; Nonionic emulsifier is selected from that fatty acid Pyrusussuriensis is smooth, Polysorbate, polyoxyethylene fatty acid ester class, polyoxyethylene aliphatic alcohol ether class, Pluronic F68 class, polyox-yethylene-polyoxypropylene block copolymer class, fatty acid monoglyceride, triglycerin fatty acid ester, polyglyceryl fatty acid ester, sucrose fatty acid ester and glyceryl monostearate one or more; Anionic emulsifier is selected from one or more mixture of sodium stearate, potassium stearate, enuatrol, potassium oleate, calcium stearate, sodium lauryl sulphate, hexadecyl hydrosulfate Oleum Ricini; Naturally occurring emulsifying agent is selected from one or more in arabic gum, tragakanta, gelatin and phospholipid.
6. treatment epilepsy in childhood drug oral Emulsion according to claim 1, it is characterized in that, described coemulsifier be the coemulsifier that increases aqueous phase viscosity and increase in the coemulsifier of oil phase viscosity one or more, the coemulsifier increasing aqueous phase viscosity is selected from one or more in methylcellulose, sodium carboxymethyl cellulose, carboxy-propyl cellulose, sodium alginate, agar, tragakanta, arabic gum, xanthan gum, guar gum, pectin, Bentonite; The coemulsifier increasing oil phase viscosity is selected from one or more in spermol, Cera Flava, glyceryl monostearate, stearic acid, stearyl alcohol, glycerol, Polyethylene Glycol, polyglycerin ester, polyvidone.
7. treatment epilepsy in childhood drug oral Emulsion according to claim 1, it is characterized in that, described antioxidant be sodium sulfite, sodium sulfite, sodium thiosulfate, sodium pyrosulfite, ascorbic acid, propyl gallate, ascorbyl palmitate, butylated hydroxyarisol, ditertbutylparacresol, vitamin E one or more.
8. treat a preparation method for epilepsy in childhood drug oral Emulsion, it is characterized in that, specifically implement according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, 40 ~ 80 DEG C of lower magnetic forces stir 10 ~ 60min, and high-speed shearing machine shears 1 ~ 30min, and embedding, sterilizing, obtains product.
9. treat a preparation method for epilepsy in childhood drug oral Emulsion, it is characterized in that, specifically implement according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, obtain oil phase, 40 ~ 80 DEG C of insulations are for subsequent use;
Step 3, will join in oil phase after purified water and coemulsifier mixed dissolution, through ultrasonic emulsator dispersion, 100W ~ 1000W, 1 ~ 5min, in triplicate, embedding, sterilizing, obtains product.
10. treat a preparation method for epilepsy in childhood drug oral Emulsion, specifically implement according to following steps:
Step 1, weighing, weigh following component according to mass parts: antiepileptic 0.1 part ~ 10 parts, medicinal oil are 1 part ~ 100 parts, emulsifying agent is 0.1 part ~ 50 parts, and coemulsifier is 0 ~ 20 part, and antioxidant is 0 part ~ 10 parts;
Step 2, prepare oil phase, by antiepileptic load weighted in step 1, medicinal oil, emulsifying agent, coemulsifier and antioxidant mix homogeneously, 40 ~ 80 DEG C of preheatings, obtained oil phase is for subsequent use;
Step 3, under slow stirring, by load weighted coemulsifier and purified water mixing, and 40 ~ 80 DEG C of preheatings, obtain co-emulsifier agent solution, in the mode of thin jet, co-emulsifier agent solution is joined in the oil phase of preheating, form stable O/W type Emulsion, embedding, sterilizing, obtains product.
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